82_FR_58205 82 FR 57970 - Certain New Chemicals or Significant New Uses; Statements of Findings for August and September 2017

82 FR 57970 - Certain New Chemicals or Significant New Uses; Statements of Findings for August and September 2017

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 235 (December 8, 2017)

Page Range57970-57971
FR Document2017-26520

Section 5(g) of the Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of TSCA section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to premanufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) submitted to EPA under TSCA section 5. This document presents statements of findings made by EPA on TSCA section 5(a) notices during the period from August 1, 2017 to September 30, 2017.

Federal Register, Volume 82 Issue 235 (Friday, December 8, 2017)
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57970-57971]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26520]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0141; FRL-9971-01]


Certain New Chemicals or Significant New Uses; Statements of 
Findings for August and September 2017

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5(g) of the Toxic Substances Control Act (TSCA) 
requires EPA to publish in the Federal Register a statement of its 
findings after its review of TSCA section 5(a) notices when EPA makes a 
finding that a new chemical substance or significant new use is not 
likely to present an unreasonable risk of injury to health or the 
environment. Such statements apply to premanufacture notices (PMNs), 
microbial commercial activity notices (MCANs), and significant new use 
notices (SNUNs) submitted to EPA under TSCA section 5. This document 
presents statements of findings made by EPA on TSCA section 5(a) 
notices during the period from August 1, 2017 to September 30, 2017.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Greg Schweer, Chemical Control Divison (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8469; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. As such, the 
Agency has not attempted to describe the specific entities that this 
action may apply to. Although others may be affected, this action 
applies directly to the submitters of the PMNs addressed in this 
action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPPT-2017-0141, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics 
Docket (OPPT Docket), Environmental Protection Agency Docket Center 
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW., Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

II. What action is the Agency taking?

    This document lists the statements of findings made by EPA after 
review of notices submitted under TSCA section 5(a) that certain new 
chemical substances or significant new uses are not likely to present 
an unreasonable risk of injury to health or the environment. This 
document presents statements of findings made by EPA during the period 
from August 1, 2017 to September 30, 2017.

III. What is the Agency's authority for taking this action?

    TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a) 
notice and make one of the following specific findings:
     The chemical substance or significant new use presents an 
unreasonable risk of injury to health or the environment;
     The information available to EPA is insufficient to permit 
a reasoned evaluation of the health and environmental effects of the 
chemical substance or significant new use;
     The information available to EPA is insufficient to permit 
a reasoned evaluation of the health and environmental effects and the 
chemical substance or significant new use may present an unreasonable 
risk of injury to health or the environment;
     The chemical substance is or will be produced in 
substantial quantities, and such substance either enters or may 
reasonably be anticipated to enter the environment in substantial 
quantities or there is or may be significant or substantial human 
exposure to the substance; or
     The chemical substance or significant new use is not 
likely to present an unreasonable risk of injury to health or the 
environment.
    Unreasonable risk findings must be made without consideration of 
costs or other non-risk factors, including an unreasonable risk to a 
potentially exposed or susceptible subpopulation identified as relevant 
under the conditions of use. The term ``conditions of use'' is defined 
in TSCA section 3 to mean ``the circumstances, as determined by the 
Administrator, under which a chemical substance is intended, known, or 
reasonably foreseen to be manufactured, processed, distributed in 
commerce, used, or disposed of.''
    EPA is required under TSCA section 5(g) to publish in the Federal 
Register a statement of its findings after its review of a TSCA section 
5(a) notice when EPA makes a finding that a new chemical substance or 
significant new use is not likely to present an unreasonable risk of 
injury to health or the environment. Such statements apply to PMNs, 
MCANs, and SNUNs sub mitted to EPA under TSCA section 5.
    Anyone who plans to manufacture (which includes import) a new 
chemical substance for a non-exempt commercial purpose and any 
manufacturer or processor wishing to engage in a use of a chemical 
substance designated by EPA as a significant new use must submit a 
notice to EPA at least 90 days before commencing manufacture of the new 
chemical substance or before engaging in the significant new use.
    The submitter of a notice to EPA for which EPA has made a finding 
of ``not likely to present an unreasonable risk of injury to health or 
the environment'' may commence manufacture of the chemical substance or 
manufacture or processing for the significant new use notwithstanding 
any remaining portion of the applicable review period.

[[Page 57971]]

IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent 
that such information is not claimed as Confidential Business 
Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this 
period, EPA has made findings under TSCA section 5(a)(3)(C) that the 
new chemical substances or significant new uses are not likely to 
present an unreasonable risk of injury to health or the environment:
     EPA case number assigned to the TSCA section 5(a) notice.
     Chemical identity (generic name, if the specific name is 
claimed as CBI).
     Web site link to EPA's decision document describing the 
basis of the ``not likely to present an unreasonable risk'' finding 
made by EPA under TSCA section 5(a)(3)(C).
    EPA Case Number: P-17-0190; Chemical identity: Butanoic acid, 3-
oxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester, polymer with 
cycloalkyl 2-methyl-2-propenoate, ethenylbenzene, 2-ethylhexyl 2- 
propenoate, methyl 2-methyl-2-propenoate and 2-methylpropyl 2-methyl-2- 
propenoate (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-76.
    EPA Case Number: P-16-0508; Chemical identity: Terephthalic acid 
and alcohol ester polymer hydroxy glycol and 2-Ethylhexyl alcohol; 
polymer exemption flag (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-74.

    Authority:  15 U.S.C. 2601 et seq.

    Dated: November 20, 2017.
Greg Schweer,
Chief, New Chemicals Management Branch, Chemical Control Division, 
Office of Pollution Prevention and Toxics.
[FR Doc. 2017-26520 Filed 12-7-17; 8:45 am]
 BILLING CODE 6560-50-P



                                                57970                        Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices

                                                  Time: 7:00 p.m.                                         For general information contact: The    environmental effects of the chemical
                                                  Location: Holiday Inn Express, 2810                   TSCA-Hotline, ABVI-Goodwill, 422          substance or significant new use;
                                                Main Street, Red Bluff, CA 96080.                       South Clinton Ave., Rochester, NY            • The information available to EPA is
                                                  At the meetings, resource agency                      14620; telephone number: (202) 554–       insufficient to permit a reasoned
                                                personnel and other interested persons                  1404; email address: TSCA-Hotline@        evaluation of the health and
                                                will have the opportunity to provide                    epa.gov.                                  environmental effects and the chemical
                                                oral and written comments and                                                                     substance or significant new use may
                                                                                                        SUPPLEMENTARY INFORMATION:
                                                recommendations regarding the draft                                                               present an unreasonable risk of injury to
                                                EIS. The meeting will be recorded by a                  I. General Information                    health or the environment;
                                                court reporter, and all statements (verbal                                                           • The chemical substance is or will
                                                                                                        A. Does this action apply to me?
                                                and written) will become part of the                                                              be produced in substantial quantities,
                                                Commission’s public record for the                         This action is directed to the public  and such substance either enters or may
                                                project. This meeting is posted on the                  in general. As such, the Agency has not   reasonably be anticipated to enter the
                                                Commission’s calendar located at http://                attempted to describe the specific        environment in substantial quantities or
                                                www.ferc.gov/EventCalendar/                             entities that this action may apply to.   there is or may be significant or
                                                EventsList.aspx along with other related                Although others may be affected, this     substantial human exposure to the
                                                information.                                            action applies directly to the submitters substance; or
                                                  For further information, contact                      of the PMNs addressed in this action.
                                                                                                                                                     • The chemical substance or
                                                Kenneth Hogan at (202) 502–8434 or at
                                                                                                        B. How can I get copies of this document significant new use is not likely to
                                                Kenneth.Hogan@ferc.gov.
                                                                                                        and other related information?            present an unreasonable risk of injury to
                                                  Dated: December 4, 2017.                                                                        health or the environment.
                                                Nathaniel J. Davis, Sr.,                                   The docket for this action, identified
                                                                                                        by docket identification (ID) number         Unreasonable risk findings must be
                                                Deputy Secretary.                                                                                 made   without consideration of costs or
                                                                                                        EPA–HQ–OPPT–2017–0141, is available
                                                [FR Doc. 2017–26499 Filed 12–7–17; 8:45 am]
                                                                                                        at http://www.regulations.gov or at the   other non-risk factors, including an
                                                BILLING CODE 6717–01–P
                                                                                                        Office of Pollution Prevention and        unreasonable risk to a potentially
                                                                                                        Toxics Docket (OPPT Docket),              exposed or susceptible subpopulation
                                                                                                        Environmental Protection Agency           identified as relevant under the
                                                ENVIRONMENTAL PROTECTION                                Docket Center (EPA/DC), West William      conditions of use. The term ‘‘conditions
                                                AGENCY                                                  Jefferson Clinton Bldg., Rm. 3334, 1301   of use’’ is defined in TSCA section 3 to
                                                                                                        Constitution Ave. NW., Washington,        mean ‘‘the circumstances, as determined
                                                [EPA–HQ–OPPT–2017–0141; FRL–9971–01]                    DC. The Public Reading Room is open       by the Administrator, under which a
                                                                                                        from 8:30 a.m. to 4:30 p.m., Monday       chemical substance is intended, known,
                                                Certain New Chemicals or Significant                                                              or reasonably foreseen to be
                                                                                                        through Friday, excluding legal
                                                New Uses; Statements of Findings for
                                                                                                        holidays. The telephone number for the manufactured, processed, distributed in
                                                August and September 2017
                                                                                                        Public Reading Room is (202) 566–1744, commerce, used, or disposed of.’’
                                                AGENCY: Environmental Protection                        and the telephone number for the OPPT        EPA is required under TSCA section
                                                Agency (EPA).                                           Docket is (202) 566–0280. Please review 5(g) to publish in the Federal Register
                                                ACTION: Notice.                                         the visitor instructions and additional   a statement of its findings after its
                                                                                                        information about the docket available    review of a TSCA section 5(a) notice
                                                SUMMARY:   Section 5(g) of the Toxic                    at http://www.epa.gov/dockets.            when EPA makes a finding that a new
                                                Substances Control Act (TSCA) requires                                                            chemical substance or significant new
                                                                                                        II. What action is the Agency taking?     use is not likely to present an
                                                EPA to publish in the Federal Register
                                                a statement of its findings after its                      This document lists the statements of  unreasonable risk of injury to health or
                                                review of TSCA section 5(a) notices                     findings made by EPA after review of      the environment. Such statements apply
                                                when EPA makes a finding that a new                     notices submitted under TSCA section      to PMNs, MCANs, and SNUNs
                                                chemical substance or significant new                   5(a) that certain new chemical            submitted to EPA under TSCA
                                                use is not likely to present an                         substances or significant new uses are    section 5.
                                                unreasonable risk of injury to health or                not likely to present an unreasonable        Anyone who plans to manufacture
                                                the environment. Such statements apply                  risk of injury to health or the           (which includes import) a new chemical
                                                to premanufacture notices (PMNs),                       environment. This document presents       substance for a non-exempt commercial
                                                microbial commercial activity notices                   statements of findings made by EPA        purpose and any manufacturer or
                                                (MCANs), and significant new use                        during the period from August 1, 2017     processor wishing to engage in a use of
                                                notices (SNUNs) submitted to EPA                        to September 30, 2017.                    a chemical substance designated by EPA
                                                under TSCA section 5. This document                                                               as a significant new use must submit a
                                                                                                        III. What is the Agency’s authority for
                                                presents statements of findings made by                                                           notice to EPA at least 90 days before
                                                                                                        taking this action?
                                                EPA on TSCA section 5(a) notices                                                                  commencing manufacture of the new
                                                during the period from August 1, 2017                      TSCA section 5(a)(3) requires EPA to   chemical substance or before engaging
                                                to September 30, 2017.                                  review a TSCA section 5(a) notice and     in the significant new use.
                                                FOR FURTHER INFORMATION CONTACT: For                    make one of the following specific           The submitter of a notice to EPA for
                                                technical information contact: Greg                     findings:                                 which EPA has made a finding of ‘‘not
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                                                Schweer, Chemical Control Divison                          • The chemical substance or            likely to present an unreasonable risk of
                                                (7405M), Office of Pollution Prevention                 significant new use presents an           injury to health or the environment’’
                                                and Toxics, Environmental Protection                    unreasonable risk of injury to health or  may commence manufacture of the
                                                Agency, 1200 Pennsylvania Ave. NW.,                     the environment;                          chemical substance or manufacture or
                                                Washington, DC 20460–0001; telephone                       • The information available to EPA is processing for the significant new use
                                                number: (202) 564–8469; email address:                  insufficient to permit a reasoned         notwithstanding any remaining portion
                                                schweer.greg@epa.gov.                                   evaluation of the health and              of the applicable review period.


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                                                                             Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices                                 57971

                                                IV. Statements of Administrator                         SUMMARY:  EPA has granted or denied                   II. Background
                                                Findings Under TSCA Section 5(a)(3)(C)                  emergency exemptions under the
                                                                                                        Federal Insecticide, Fungicide, and          EPA has granted or denied emergency
                                                   In this unit, EPA provides the                                                                 exemptions to the following State
                                                following information (to the extent that               Rodenticide Act (FIFRA) for use of
                                                                                                        pesticides as listed in this notice. The  agencies. There were no emergency
                                                such information is not claimed as                                                                exemptions from any Federal agencies
                                                Confidential Business Information                       exemptions or denials were granted
                                                                                                        during the period July 1, 2017 to         during the time period covered by this
                                                (CBI)) on the PMNs, MCANs and
                                                                                                        September 30, 2017 to control             notice (July 1, 2017 through September
                                                SNUNs for which, during this period,
                                                EPA has made findings under TSCA                        unforeseen pest outbreaks.                30, 2017).
                                                section 5(a)(3)(C) that the new chemical                FOR FURTHER INFORMATION CONTACT:             The emergency exemptions may take
                                                substances or significant new uses are                  Michael L. Goodis, Registration Division  the following form: Crisis, public health,
                                                not likely to present an unreasonable                   (7505P), Office of Pesticide Programs,    quarantine, or specific. EPA has also
                                                risk of injury to health or the                         Environmental Protection Agency, 1200     listed denied emergency exemption
                                                environment:                                            Pennsylvania Ave. NW., Washington,        requests in this notice.
                                                   • EPA case number assigned to the                    DC 20460–0001; main telephone
                                                                                                                                                     Under FIFRA section 18 (7 U.S.C.
                                                TSCA section 5(a) notice.                               number: (703) 305–7090; email address:
                                                                                                                                                  136p), EPA can authorize the use of a
                                                   • Chemical identity (generic name, if                RDFRNotices@epa.gov.
                                                                                                                                                  pesticide when emergency conditions
                                                the specific name is claimed as CBI).                   SUPPLEMENTARY INFORMATION:                exist. Authorizations (commonly called
                                                   • Web site link to EPA’s decision
                                                                                                        I. General Information                    emergency exemptions) are granted to
                                                document describing the basis of the
                                                ‘‘not likely to present an unreasonable                                                           State and Federal agencies and are of
                                                                                                        A. Does this action apply to me?
                                                risk’’ finding made by EPA under TSCA                                                             four types:
                                                section 5(a)(3)(C).                                        You may be potentially affected by        1. A ‘‘specific exemption’’ authorizes
                                                   EPA Case Number: P–17–0190;                          this action if you are an agricultural    use of a pesticide against specific pests
                                                Chemical identity: Butanoic acid,                       producer, food manufacturer, or           on a limited acreage in a particular
                                                3-oxo-, 2-[(2-methyl-1-oxo-2-propen-1-                  pesticide manufacturer. The following
                                                                                                                                                  State. Most emergency exemptions are
                                                yl)oxy]ethyl ester, polymer with                        list of North American Industrial
                                                                                                                                                  specific exemptions.
                                                cycloalkyl 2-methyl-2-propenoate,                       Classification System (NAICS) codes is
                                                                                                        not intended to be exhaustive, but rather    2. ‘‘Quarantine’’ and ‘‘public health’’
                                                ethenylbenzene, 2-ethylhexyl 2-                                                                   exemptions are emergency exemptions
                                                propenoate, methyl 2-methyl-2-                          provides a guide to help readers
                                                                                                        determine whether this document           issued for quarantine or public health
                                                propenoate and 2-methylpropyl 2-
                                                                                                        applies to them. Potentially affected     purposes. These are rarely requested.
                                                methyl-2- propenoate (generic name);
                                                Web site link: https://www.epa.gov/                     entities may include:                        3. A ‘‘crisis exemption’’ is initiated by
                                                reviewing-new-chemicals-under-toxic-                       • Crop production (NAICS code 111). a State or Federal agency (and is
                                                substances-control-act-tsca/tsca-section-                  • Animal production (NAICS code        confirmed by EPA) when there is
                                                5a3c-determination-76.                                  112).                                     insufficient time to request and obtain
                                                   EPA Case Number: P–16–0508;                             • Food manufacturing (NAICS code       EPA permission for use of a pesticide in
                                                Chemical identity: Terephthalic acid                    311).                                     an emergency.
                                                and alcohol ester polymer hydroxy                          • Pesticide manufacturing (NAICS
                                                                                                        code 32532).                                 EPA may deny an emergency
                                                glycol and 2-Ethylhexyl alcohol;                                                                  exemption:    If the State or Federal
                                                polymer exemption flag (generic name);                     If you have any questions regarding
                                                                                                        the applicability of this action to a     agency cannot demonstrate that an
                                                Web site link: https://www.epa.gov/
                                                                                                        particular entity, consult the person     emergency exists, if the use poses
                                                reviewing-new-chemicals-under-toxic-
                                                                                                        listed at the end of the emergency        unacceptable risks to the environment,
                                                substances-control-act-tsca/tsca-section-
                                                5a3c-determination-74.                                  exemption or denial.                      or if EPA cannot reach a conclusion that
                                                                                                                                                  the proposed pesticide use is likely to
                                                   Authority: 15 U.S.C. 2601 et seq.                    B. How can I get copies of this document result in ‘‘a reasonable certainty of no
                                                  Dated: November 20, 2017.                             and other related information?            harm’’ to human health, including
                                                Greg Schweer,                                              The docket for this action, identified exposure of residues of the pesticide to
                                                Chief, New Chemicals Management Branch,                 by docket identification (ID) number      infants and children.
                                                Chemical Control Division, Office of Pollution          EPA–HQ–OPP–2017–0009, is available           If the emergency use of the pesticide
                                                Prevention and Toxics.                                  at https://www.regulations.gov or at the  on a food or feed commodity would
                                                [FR Doc. 2017–26520 Filed 12–7–17; 8:45 am]             Office of Pesticide Programs Regulatory   result in pesticide chemical residues,
                                                BILLING CODE 6560–50–P                                  Public Docket (OPP Docket) in the         EPA establishes a time-limited tolerance
                                                                                                        Environmental Protection Agency           meeting the ‘‘reasonable certainty of no
                                                                                                        Docket Center (EPA/DC), West William      harm standard’’ of the Federal Food,
                                                ENVIRONMENTAL PROTECTION                                Jefferson Clinton Bldg., Rm. 3334, 1301
                                                AGENCY                                                                                            Drug, and Cosmetic Act (FFDCA).
                                                                                                        Constitution Ave. NW., Washington, DC
                                                                                                        20460–0001. The Public Reading Room          In this document: EPA identifies the
                                                [EPA–HQ–OPP–2017–009; FRL–9971–02]                      is open from 8:30 a.m. to 4:30 p.m.,      agency granted the exemption or denial,
                                                                                                        Monday through Friday, excluding legal the type of exemption, the pesticide
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                                                Pesticide Emergency Exemptions;                         holidays. The telephone number for the authorized and the pests, the crop or use
                                                Agency Decisions and State and                          Public Reading Room is (202) 566–1744, for which authorized, number of acres
                                                Federal Agency Crisis Declarations                      and the telephone number for the OPP      (if applicable), and the duration of the
                                                AGENCY: Environmental Protection                        Docket is (703) 305–5805. Please review exemption. EPA also gives the citation
                                                Agency (EPA).                                           the visitor instructions and additional   in Title 40 of the Code of Federal
                                                                                                        information about the docket available    Regulations (40 CFR) for the time-
                                                ACTION: Notice.
                                                                                                        at https://www.epa.gov/dockets.           limited tolerance(s), if any.


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Document Created: 2017-12-08 01:43:20
Document Modified: 2017-12-08 01:43:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFor technical information contact: Greg Schweer, Chemical Control Divison (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
FR Citation82 FR 57970 

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